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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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OsteoSparx C Putty, 10cc - derived from selected donated human bone tissue that has been processed into particles. The particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
56230100
In Commercial Distribution

  • M386562301001 ()
  • 10889981055783 ()

  • 10cc
56230100

  • Bone matrix implant, human-derived
OsteoSparx C Paste, 8cc - derived from selected donated human bone tissue that has been processed into particles. The particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
56220080
In Commercial Distribution

  • M386562200801 ()
  • 10889981055769 ()

  • 8cc
56220080

  • Bone matrix implant, human-derived
OsteoSparx C Paste, 1cc - derived from selected donated human bone tissue that has been processed into particles. The particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
56220010
In Commercial Distribution

  • M386562200101 ()
  • 10889981055745 ()

  • 1cc
56220010

  • Bone matrix implant, human-derived
OsteoSparx Putty, 5cc - derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a gel or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
56210050
In Commercial Distribution

  • M386562100501 ()
  • 10889981055721 ()

  • 5cc
56210050

  • Bone matrix implant, human-derived
OsteoSparx Putty, 2.5cc - derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a gel or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
56210025
In Commercial Distribution

  • M386562100251 ()
  • 10889981055714 ()

  • 2.5cc
56210025

  • Bone matrix implant, human-derived
OsteoSparx Gel, 10cc - derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a gel or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
56200100
In Commercial Distribution

  • M386562001001 ()
  • 10889981055691 ()

  • 10cc
56200100

  • Bone matrix implant, human-derived
OsteoSparx Gel, 1cc - derived from selected donated human bone tissue that has been processed into particles. The bone particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with an inert reverse phase carrier and formulated to a gel or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
56200010
In Commercial Distribution

  • M386562000101 ()
  • 10889981055677 ()

  • 1cc
56200010

  • Bone matrix implant, human-derived
Accell TBM, 5x5 - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM is not an injectable putty.
ISOTIS ORTHOBIOLOGICS, INC.
02-4000-550
In Commercial Distribution

  • M3860240005501 ()
  • 10889981055653 ()

  • 5cmx5cm
02-4000-550

  • Bone matrix implant, human-derived
Accell TBM, 5x2 - is made using demineralized human bone and is provided in the form of a freeze-dried matrix in a sheet or “wafer” format. Accell TBM is not an injectable putty.
ISOTIS ORTHOBIOLOGICS, INC.
02-4000-520
In Commercial Distribution

  • M3860240005201 ()
  • 10889981055646 ()

  • 5cmX2cm
02-4000-520

  • Bone matrix implant, human-derived
OrthoBlast II Paste, 8cc - derived from selected donated human bone tissue that has been processed into particles. The particles are subsequently demineralized using a hydrochloric acid process. The demineralized bone matrix (DBM) is combined with a reverse phase carrier, cancellous chips from the same donor, and then formulated to a paste or putty-like consistency.
ISOTIS ORTHOBIOLOGICS, INC.
02-2100-080
In Commercial Distribution

  • M3860221000801 ()
  • 10889981055615 ()

  • 8cc
02-2100-080

  • Bone matrix implant, human-derived
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